Heart FailureNCT07036289
Periodontitis Treatment and Heart Failure
A study testing Mechanical Treatment in people with Heart Failure and Periodontitis, run by University of Taubate at 1 site in Brazil.
Trial summary
Heart failure (HF) is a rapidly growing public health issue affecting more than 40 million individuals globally; while gum disease with bone loss affects 50% of people in general. The objective of this study is to evaluate the effect of dental treatment on blood levels of a HF parameter at 3 and at 6 months. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Periodontitis
- What is being tested?
- Mechanical Treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- minimum of 35 years of age;
- possibility and availability for medical and dental examinations;
- specifically for HF groups: HF having as primary causes ischemic problems, myocardial infarction, hypertension and valvulopathies will be selected
- HF with intermediate or reduced ejection fraction under one of the three following pharmacological therapeutic regimens: a) Angiotensin Converting Enzyme Inhibitors, as the first option, or b) Angiotensin II Receptor Blockers and b) Angiotensin II Receptor Blockers and c) Angiotensin/neprilysin receptor inhibitors.
Who cannot join
- pregnant or lactating women;
- individuals with stage D of HF using vasoactive drugs or circulatory devices;
- HF individuals with preserved ejection fraction;
- participants who do not meet the criteria for periodontal disease;
- participants who are unable to comply with the study protocol;
- diabetes, obesity, chronic kidney disease and other non-ischemic causes of HF;
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- familial and congenital heart alterations and myocarditis
- rheumatological and autoimmune diseases;
- drugs and cardiotoxic substances such as cocaine and oncological chemotherapy;
- Specifically for the negative control group a progression of periodontitis revealed by 0.3mm additional clinical attachment loss within 6 months of follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of PeriodontitisTtreatment On The Worsening Of Heart Failure: A Randomized Clinical Trial
Heart failure (HF) is a rapidly growing public health issue affecting more than 40 million individuals globally; while gum disease with bone loss affects 50% of people in general. The objective of this study is to evaluate the effect of dental treatment on blood levels of a HF parameter at 3 and at 6 months. In addition to verify the relation between blood and salivary exam results and severity of HF. Imune response against one important oral bacterial will be also monitored at 3 and 6 months. Approximately 80 adult individuals will be included and divided into 3 groups. The first two groups will receive dental scaling and root planing (periodontitis individuals with heart failure [n = 25]; periodontitis individuals without heart failure [n = 25]). The third group named negative control will receive dental treatment only after 6 months of dental follow-up (periodontitis individuals with heart failure [n = 25]). HF treatment by oral medication will be continuous. Blood, salivary, microbiological and immune examinations will be performed in addition to the periodontal treatment of scaling and root planning. Clinical data will be obtained both for initial diagnosis and disease staging and for longitudinal follow-up.
Read the detailed description
Heart failure (HF) is a rapidly growing public health issue with an estimated prevalence of > 40 million individuals globally; while periodontitis affects 50% of people in general, and its most severe form affects approximately 11% of the population. The primary objective of this study is to evaluate the effect of periodontal therapy on blood levels of NT-proBNP (N-terminal pro-B-type natriuretic peptide) at 3 and at 6 months. Secondary aims are the relation between biomarker blood levels and a) functional classes and b) its salivary levels. Antibodies against P. gingivalis besides species' levels will be also determined initially and at 3 and 6 months. As 66 participants must complete the study, 75 to 85 individuals over 35 years of age will be included and randomly assigned to dental scaling and root planing (periodontitis individuals with heart failure [n = 25]; periodontitis individuals without heart failure [n = 25]) or negative control (periodontitis individuals with heart failure [n = 25]). Blood, salivary, microbiological and immune examinations will be performed in addition to the periodontal treatment of scaling and root planning. Clinical data will be obtained both for initial diagnosis and disease staging and for longitudinal follow-up. NT-proBNP and antibodies against P. gingivalis will be evaluated by enzyme immunoassay using commercially available kits while P. gingivalis levels will be determined by quantitative polymerase chain reaction (qPCR).
- Conditions
- Heart Failure, Periodontitis
- Being tested
- Mechanical Treatment
- Keywords
- scaling and root planing, heart failure, periodontitis, NT-proBNP, saliva, blood, Porphyromonas Gingivalis
- Medical subject headings
- Heart Failure, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical TreatmentProcedure or surgery
manual quadrant scaling and root planing followed by dental prophylaxis within 4 weekly sections and oral hygiene instructions
| Study group | Role | What they receive |
|---|---|---|
| periodontitis heart failure mechanical treatment | Experimental | scaling and root planing plus oral hygiene instructions Receives: Procedure: Mechanical Treatment |
| periodontitis mechanical treatment | Active comparator | scaling and root planing plus oral hygiene instructions Receives: Procedure: Mechanical Treatment |
| periodontitis heart failure control | No intervention | oral hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
NT-proBNP in blood samples
Changes in NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels in blood samples. Higher levels indicate worse heart failure status.
Measured: baseline versus 6 months
Secondary outcomes (6)
Salivary NT-proBNP
Comparative NT-proBNP levels between blood and saliva samples at each time-point
Measured: baseline, 3 and 6 months
clinical pocket depth response
Changes in periodontal pocket depth (mm). Higher values indicate deeper periodontal pockets.
Measured: baseline, 3 and 6 months
clinical attachment level response
Changes in periodontal clinical attachment level (mm). Higher values indicate worse periodontal breakdown.
Measured: baseline, 3 and 6 months
clinical bleeding response
Changes in bleeding on probing (0 indicates absence and 1 presence of bleeding onto gentle periodontal probing).
Measured: baseline, 3 and 6 months
P. gingivalis bacterium salivary levels
- gingivitis bacterium levels in saliva samples
Measured: baseline and 3 months
P. gingivalis antibody salivary levels
Antibodies against P. gingivitis in saliva samples
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start10 Jun 2025
- Primary completion30 Dec 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Taubate
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Minas Gerais, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Jose Roberto Cortelli, University of Taubate
- Investigators
- Jose R Cortelli, Doctorate, Principal investigator, University of Taubate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036289
- Sponsor's protocol ID
- CAAE 76621623.3.00000.5501
- Other IDs
- 2023/07458-4, 306161/2023, 2023
- Status last verified
- Feb 2026
- First submitted
- 14 Jun 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be analyzed by blind statistics and laboratorial staff and there is no need for sharing IPD.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of PeriodontitisTtreatment On The Worsening Of Heart Failure: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07036289
- Acronym / sponsor ID
- CAAE 76621623.3.00000.5501
- Conditions
- Heart Failure, Periodontitis
- Keywords
- scaling and root planing, heart failure, periodontitis, NT-proBNP, saliva, blood, Porphyromonas Gingivalis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of TaubateUniversity, hospital or other
- Collaborators
- Federal University of Minas Gerais, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart failure (HF) is a rapidly growing public health issue affecting more than 40 million individuals globally; while gum disease with bone loss affects 50% of people in general. The objective of this study is to evaluate the effect of dental treatment on blood levels of a HF parameter at 3 and at 6 months. In addition to verify the relation between blood and salivary exam results and severity of HF. Imune response against one important oral bacterial will be also monitored at 3 and 6 months. Approximately 80 adult individuals will be included and divided into 3 groups. The first two groups will receive dental scaling and root planing (periodontitis individuals with heart failure [n = 25]; periodontitis individuals without heart failure [n = 25]). The third group named negative control will receive dental treatment only after 6 months of dental follow-up (periodontitis individuals with heart failure [n = 25]). HF treatment by oral medication will be continuous. Blood, salivary, microbiological and immune examinations will be performed in addition to the periodontal treatment of scaling and root planning. Clinical data will be obtained both for initial diagnosis and disease staging and for longitudinal follow-up.
Detailed description
Heart failure (HF) is a rapidly growing public health issue with an estimated prevalence of > 40 million individuals globally; while periodontitis affects 50% of people in general, and its most severe form affects approximately 11% of the population. The primary objective of this study is to evaluate the effect of periodontal therapy on blood levels of NT-proBNP (N-terminal pro-B-type natriuretic peptide) at 3 and at 6 months. Secondary aims are the relation between biomarker blood levels and a) functional classes and b) its salivary levels. Antibodies against P. gingivalis besides species' levels will be also determined initially and at 3 and 6 months. As 66 participants must complete the study, 75 to 85 individuals over 35 years of age will be included and randomly assigned to dental scaling and root planing (periodontitis individuals with heart failure [n = 25]; periodontitis individuals without heart failure [n = 25]) or negative control (periodontitis individuals with heart failure [n = 25]). Blood, salivary, microbiological and immune examinations will be performed in addition to the periodontal treatment of scaling and root planning. Clinical data will be obtained both for initial diagnosis and disease staging and for longitudinal follow-up. NT-proBNP and antibodies against P. gingivalis will be evaluated by enzyme immunoassay using commercially available kits while P. gingivalis levels will be determined by quantitative polymerase chain reaction (qPCR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| periodontitis heart failure mechanical treatment | Experimental | Procedure: Mechanical Treatmentscaling and root planing plus oral hygiene instructions |
| periodontitis mechanical treatment | Active comparator | Procedure: Mechanical Treatmentscaling and root planing plus oral hygiene instructions |
| periodontitis heart failure control | No intervention | –oral hygiene instructions |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- minimum of 35 years of age;
- possibility and availability for medical and dental examinations;
- specifically for HF groups: HF having as primary causes ischemic problems, myocardial infarction, hypertension and valvulopathies will be selected
- HF with intermediate or reduced ejection fraction under one of the three following pharmacological therapeutic regimens: a) Angiotensin Converting Enzyme Inhibitors, as the first option, or b) Angiotensin II Receptor Blockers and b) Angiotensin II Receptor Blockers and c) Angiotensin/neprilysin receptor inhibitors.
Key exclusion criteria (10 listed)
- pregnant or lactating women;
- individuals with stage D of HF using vasoactive drugs or circulatory devices;
- HF individuals with preserved ejection fraction;
- participants who do not meet the criteria for periodontal disease;
- participants who are unable to comply with the study protocol;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical Treatmentmanual quadrant scaling and root planing followed by dental prophylaxis within 4 weekly sections and oral hygiene instructions | Procedure or surgery | periodontitis heart failure mechanical treatment, periodontitis mechanical treatment |
Primary outcome
NT-proBNP in blood samples
Time frame: baseline versus 6 months
Changes in NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels in blood samples. Higher levels indicate worse heart failure status.
6 secondary outcomes
Salivary NT-proBNP
Time frame: baseline, 3 and 6 months
clinical pocket depth response
Time frame: baseline, 3 and 6 months
clinical attachment level response
Time frame: baseline, 3 and 6 months
clinical bleeding response
Time frame: baseline, 3 and 6 months
P. gingivalis bacterium salivary levels
Time frame: baseline and 3 months
P. gingivalis antibody salivary levels
Time frame: baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No. Data will be analyzed by blind statistics and laboratorial staff and there is no need for sharing IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose R Cortelli, Doctorate principal investigator
University of Taubate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Treatment in people with Heart Failure and Periodontitis, run by University of Taubate at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NT-proBNP in blood samples (time frame: baseline versus 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.